NCT01309841

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 652 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

Conditions

• Opioid-Induced Constipation (OIC)

Interventions

Type	Name	Description
DRUG	NKTR-118	12.5 mg oral tablet once daily
DRUG	NKTR-118	25 mg oral tablet once daily
DRUG	Placebo	Oral tablet once daily

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-03-07
• Last updated: 2015-06-01
• Results posted: 2015-06-01

Locations

117 sites across 4 countries: United States, Australia, Germany, Slovakia